APOL1 Gene Variants in African American Kidney Transplant Recipients

Kidney Failure, Chronic Clinical Trial

Official title:

Impact of APOL1 Gene Variants in African American Kidney Transplant Recipients: A Study of Clinical Outcomes and Molecular Mechanisms

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01442402
• Other study ID #: 2011P000734
• Status: Terminated
• Start date: April 2014
• Est. completion date: April 2014

Study information

• Verified date: January 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Aim 1:

Determine if there is an association between the APOL1 risk variants and allograft survival and function in African Americans

Aim 2:

Determine if there is an association between the presence of APOL1 risk variants in an African American kidney transplant recipient and the risk of recurrent disease

Aim 3:

Investigate mechanisms of APOL1 associated kidney disease by prospectively following African American kidney transplant recipients throughout their clinical course.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Aim 1:

Inclusion Criteria:

• self-reported African American

• 18 years or older

• kidney transplant within 12 years

Aim 2:

Inclusion Criteria for patients with recurrent disease:

• self-reported African American

• 18 years or older

• kidney transplant within 12 years

• recurrent or de novo glomerular disease on allograft kidney biopsy

Inclusion Criteria for control group:

• self-reported African American

• 18 years or older

• kidney transplant within 12 years

• end stage kidney disease due to glomerular nephritis, clinically diagnosed or by native kidney biopsy

Exclusion Criteria for control group:

• clinical evidence of recurrent disease (presence of proteinuria, hematuria, Creatinine >2)

Aim 3:

Inclusion Criteria:

• self-reported African American

• 18 years or older

• scheduled living kidney transplant

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Transplant;Failure,Kidney

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allograft survival		year 1, 3, 5
Secondary	Allograft function as measured by serum creatinine		creatinine levels at year-1, year-3 and year-5